Heartware, Inc.: 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN

Hazard

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Details from the source

Reason for recall: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components Distribution: Worldwide Quantity: 6 units Lot/code info: Serial numbers: HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.